Recovery Information for Acute Kidney Injury

(ORKID-2 Trial)

Overseen By Ian E McCoy, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Pregnant, Prisoner, Unable to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether providing extra recovery information to patients with acute kidney injury (AKI) who continue dialysis after hospital discharge can be beneficial. The goal is to determine if sharing details about a patient's remaining kidney function and advice on dialysis scheduling with both the patient and their kidney doctor improves care. Participants are divided into two groups: one receives this extra information, and the other does not, allowing for outcome comparison. This trial may suit individuals who have experienced acute kidney injury and continue dialysis outside the hospital. As an unphased trial, it offers a unique opportunity to contribute to understanding how additional information can enhance patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this protocol is safe for patients with acute kidney injury?

Research has shown that providing more information about recovering from acute kidney injury (AKI) can assist patients who require dialysis after hospital discharge. This trial does not test a new drug or treatment. Instead, it focuses on sharing crucial recovery information to manage dialysis more effectively.

The main goal is to monitor kidney function and use this data to adjust dialysis schedules, potentially reducing sessions to twice a week. Since no new medicine or procedure is being tested, the safety concerns typical of drug trials do not apply. The aim is to enhance how patients and doctors manage current treatments.

With no new medication involved, the risks are very low. The study seeks to help patients and doctors make informed choices, ensuring participation remains quite safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how additional recovery information can aid patients with Acute Kidney Injury (AKI-D). Unlike standard treatments that focus solely on medical intervention, this approach emphasizes the power of information and education in recovery. By providing extra details on AKI-D recovery, the trial aims to empower patients with knowledge that could improve their recovery outcomes and potentially reduce complications. This method shifts the focus from just treating the condition to also enhancing patient understanding and involvement in their health journey.

What evidence suggests that this method is effective for acute kidney injury?

Studies have shown that many patients with sudden kidney problems (acute kidney injury or AKI) who require dialysis after hospitalization can regain kidney function over time. Research suggests that remote patient monitoring can enhance care for those recovering from AKI by providing better tracking and advice. About one-third of patients who needed dialysis in the hospital continue to require it after discharge. However, around 24% to 34% of those with severe kidney issues due to AKI improve within a year. In this trial, some participants will receive additional AKI-D recovery information, potentially aiding doctors in determining the safety and effectiveness of reducing dialysis sessions. ^{1 6 7 8 9}

Who Is on the Research Team?

Ian E McCoy, MD, MS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for patients who have acute kidney injury and still need dialysis after leaving the hospital. They should be under a nephrologist's care. Specific eligibility criteria are not provided, so it's important to contact the study team for detailed requirements.

Inclusion Criteria

I am scheduled for ongoing dialysis at a facility outside of a short-stay hospital.

I am 18 years old or older.

I have acute kidney injury but not end-stage kidney disease.

Exclusion Criteria

Pregnant

Prisoner

Clinical team declines to allow approach for study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive information on residual kidney function and recommended recovery monitoring frequency

8 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transmission of additional AKI-D recovery information

Trial Overview The study tests if giving extra recovery information to these patients and their kidney doctors helps manage their condition better. It includes measuring residual kidney function at discharge, sharing results with both patient and doctor, plus advice on monitoring and dialysis scheduling.

How Is the Trial Designed?

Group I: Additional AKI-D recovery information Experimental Treatment 1 Intervention

Group II: No additional AKI-D recovery information Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8655552/

Association of persistent acute kidney injury and renal ... Persistent AKI without renal recovery was associated with approximately fivefold increased hazard rates compared with no AKI in all cohort and ICU and non-ICU ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S259005952400116X

Acute Kidney Injury Survivor Remote Patient Monitoring Remote patient monitoring (RPM) could improve the quality and efficiency of acute kidney injury (AKI) survivor care.

3. academic.oup.com academic.oup.com/ckj/article/17/5/sfae085/7642252

clinical score to predict recovery in end-stage kidney disease ... Twenty-four percent and 34% of patients with ESKD due to AKI recovered kidney function within 90 days and 12 months, respectively. Factors ...

4. journals.lww.com journals.lww.com/kidney360/fulltext/2024/01000/optimum_care_of_aki_survivors_not_requiring.18.aspx

Optimum Care of AKI Survivors Not Requiring Dialysis after... AKI affects one in five hospitalized patients and is associated with poor short-term and long-term clinical and patient-centered outcomes.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10914193/

Challenges in the Care of Patients with AKI Receiving ... Up to one third of survivors of AKI that required dialysis (AKI-D) during hospitalization remain dialysis dependent at hospital discharge.

6. journals.lww.com journals.lww.com/kidney360/fulltext/2024/02000/challenges_in_the_care_of_patients_with_aki.16.aspx

Challenges in the Care of Patients with AKI Receiving... Patients with AKI face high risk for rehospitalization, 4 progression to kidney failure, and death, compared with those patients who did not develop AKI.

7. freseniusmedicalcare.com freseniusmedicalcare.com/en-us/insights/amr/2019/acute-kidney-injury-necessitating-outpatient-dialysis/

Acute Kidney Injury Necessitating Outpatient Dialysis Outcomes at 90 days of AKI-D were notable for the following: 36 percent of patients recovered kidney function, 37 percent transitioned to ESRD, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2468024920314303

Review Quality of Care for Acute Kidney Disease This review will provide specific evidence-based and expert opinion–based guidance for the care of patients with AKI or AKD after hospital discharge.

9. nature.com nature.com/articles/s41598-023-45006-5

Clinical courses of acute kidney injury in hospitalized patients We quantified AKI trajectories and describe transitions through progression and recovery among hospitalized patients.